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DEDICATED AND CRYSTAL CLEAR
Our consultants, scientists and project managers use their knowledge and experience to design and carry out complete programs for each NCE or biological from lead to Phase I clinical trials. Toxicology studies for supporting your IND / NDA. Services range from in vitro genetic testing (Ames, Chromosome Aberration, Micronucleus) to full regulatory in vivo studies; acute to chronic toxicity, carcinogenicity, developmental studies and reproduction, safety pharmacology (core battery), microdosing (phase 0), immunotoxicology (core battery) and environmental risk assessment (CHMP/SWP/4447/007). Environmental Risk Assessments for pharmaceuticals are performed routinely. On top of the regulatory studies we use tailor-made in vitro and in vivo ADME techniques to help profile your drug candidate or metabolite. Studies are conducted in a wide variety of rodent and non-rodent animal species using all common routes of administration. Full analytical support includes formulation analysis, bioanalysis, biomarkers and cytokine analysis.
DEDICATED AND CRYSTAL CLEAROur consultants, scientists and project managers use their knowledge and experience to design and carry out complete programs for each NCE or biological from lead to Phase I clinical trials. Toxicology studies for supporting your IND / NDA. Services range from in vitro genetic testing (Ames, Chromosome Aberration, Micronucleus) to full regulatory in vivo studies; acute to chronic toxicity, carcinogenicity, developmental studies and reproduction, safety pharmacology (core battery), microdosing (phase 0), immunotoxicology (core battery) and environmental risk assessment (CHMP/SWP/4447/007). Environmental Risk Assessments for pharmaceuticals are performed routinely. On top of the regulatory studies we use tailor-made in vitro and in vivo ADME techniques to help profile your drug candidate or metabolite. Studies are conducted in a wide variety of rodent and non-rodent animal species using all common routes of administration. Full analytical support includes formulation analysis, bioanalysis, biomarkers and cytokine analysis.
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